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D u e t o h i g h v o l a t i l i t y a n d t h erefore extreme potential environmental mobility, in acute phases of a nuclear accident radioactive isotopes of iodine pose serious risk. The critical organ for iodine is a thyroid. A number of studies dealing with thyroid protection from exposure to radioiodine have shown that radioiodine uptake by thyroid can be effectively blocked by administration of stable iodine, usually in the form of potassium iodine pills. However, this protective action requires precise timing, otherwise is counterproductive. International Atomic Energy Agency recommends potassium iodide prophylaxis in cases when an avertable thyroid dose by protective action exceeds 100 mGy. In this paper is given review of the experiences and practices on potassium iodide on thyroid protection. These informations are necessary in discussion and decision making process on KI prophylactic programmes in nuclear emergency situations in Croatia. If Croatia adopts such programme, it still remains to develop the most effective way of KI stockpiling and di s t r i b u t i o n o r p r e d i s t r i b u t i o n .
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Z b o g v e l i k e h l a p l j i v o s t i , t e s t o g a p o t e n c i j a l n o v r l o b r z o g ai r e n j a k r o z o k o l i a, u a k u t n o j f a z i n e s r e e n e k o g n u k l e a r n o g p o s t r o j e n j a p r i m a r n u o p a s n o s t g l e d e i z l a g a n j a r a d i o a k t i v n o m o b l a k u p r e d s t a v l j a j u r a d i o a k t i v n i i z o t o p i j o d a . K r i t i
a n o r g a n z a j o d j e at i t n j a
a . B r o j n e s t u d i j e o z a at i t i at i t n j a
e o d k o n t a m i n a c i j e r a d i o a k t i v n i m i z o t o p i m a j o d a s u g l a s n e s u d a j e u
i n k o v i t i n a
i n z a at i t e at i t n j a
e u n o s s t a b i l n o g j o d a u o r g a n i z a m , o b i
n o u o b l i k u p i l u l a k a l i j e v a j o d i d a . N o , t a z a at i t n a m j e r a m o r a b i t i p r a v o d o b n o p r o v e d e n a , i n a
e i m a s u p r o t n e u
i n k e . P r e p o r u k a M e u n a r o d n e a g e n c i j e z a a t o m s k u e n e r g i j u j e s t d a s e p r o f i l a k s i k a l i j e v i m j o d i d o m p r i s t u p a u k o l i k o s e p r o c i j e n i d a b i d o z a k o j u at i t n j a
a p r i m i u s l i j e d i z l a g a n j a r a d i o a k t i v n i m i z o t o p i m a j o d a m o g l a p r e m a ai t i 1 0 0 m G y . U r a d u j e d a n p r e g l e d d o s a d a an j i h s p o z n a j a o u
i n k o v i t o s t i z a at i t e at i t n j a
e k a l i j e v i m j o d i d o m . O v e s u p a k i n f o r m a c i j e p o t r e b n e z a i n i c i r a n j e r a s p r a v e i d o n o ae n j e o d l u k e o p r o g r a m u K I p r o f i l a k s e u H r v a t s k o j u s l u
a j u k r i z n o g a s t a n j a g l e d e n u k l e a r n e s i g u r n o s t i . U k o l i k o H r v a t s k a p r i h v a t i t a k a v p r o g r a m , p o t r e b n o j e r a z v i t i n a j u
i n k o v i t i j i n a
i n u s k l a d i at e n j a , r a s p o d j e l e i l i p r e v e n t i v n e r a s p o d j e l e K I .
K l j u
n e r i j e
i : 1 3 1 I , at i t n j a
a , K I e f i k a s n o s t , p r i p r a v n o s t u k r i z n i m s t a n j i m a
I n t r o d u c t i o n
I o d i n e i s a h i g h l y v o l a t i l e e l e m e n t , t h e r e f o r e v e r y m o b i l e i n t h e e n v i r o n m e n t . I t i s n o n - u n i f o r m l y d i s t r i b u t e d i n n a t u r e , i t s a b u n d a n c e i n t h e l i t osphere being approximately 5 times greater than in the ocean waters. There are at least 25 iodine isotopes with mass numbers ranging from 117 to 141, all except 127I being radioactive (1, 2). From the point of view of environmental contamination, and resulting doses to man, the most important isotopes of iodine are 131I and 129I. They are the only radioactive isotopes of iodine produced by fission that have half-lives longer than one day. 131I is a beta emitter with a half-life of 8.06 days and maximum beta energy of 0.81 MeV, emitting also gamma rays of 0.36 and 0.64 MeV and some other energies. 129I has very long half life (1.57107 years). It is also a beta emitter with maximum energy of 0.15 MeV, with accompanying gamma ray of 0.09 MeV in 8% of the disintegrations. Like any other fission product, these two radionuclides are present in the environment as a result of a spontaneous fission of natural uranium. However, the main source of 131I and 129I are nuclear explosions and releases from nuclear reactors and spent nuclear fuel reprocessing plants. In the Pressurized Water Reactor (PWR) type nuclear power plants, the equilibrium activity of 131I is established after a few weeks of irradiation of uranium fuel in a nuclear reactor at a value of 31015 Bq per MW(e) (1). This value slightly increases, as burn-up of nuclear fuel proceeds to the end of fuel cyclus, as a result of a larger fission yield of plutonium, which also contributes to the build-up of 131I activity concentrations. The activity of 129I produced in a nuclear reactor is much lower than that of 131I, the inventory of 129I after three years of fuel irradiation being 1.5108 Bq per MW(e). In the case of severe accidents of PWR nuclear power plant, the conservative assessment is that in the environment would be released 95% of noble gasses (Xe and Kr) contained in the core, 25-35% of iodine and caesium, and up to 10% of other activation and fission products, including 90Sr. In the acute phase of the accident, due to high volatility the plume (cloud-like formation) of radioactive material that might be released in the environment in the case of a serious nuclear accident, primarily consists of the radioactive isotopes of iodine, especially 131I as well as of noble gases.
Emergency preparedness
Iodine enters the metabolism of living organisms and is selectively taken up and concentrated in the thyroid gland. According to simple three-compartment model adopted by the International Commission on Radiological Protection (ICRP), of iodine entering the body transfer compartment 30% is assumed to be translocated to the thyroid, while the remainder is assumed to go directly to excretion (3). Iodine in the thyroid is assumed to be retained with a biological half-life of 120 days, which is, luckily about 15 radiological half-lifes of 131I. However, in all other organs than the thyroid the biological half-life of iodine is 12 days (3). However, the effective half life in a thyroid (time for the thyroid to obtain one-half of its maximal burden during chronic exposure) was estimated to be 7.6 days (4). Therefore, in the case of a severe nuclear accident it is essential to protect general public from the plume exposure pathway. The principal exposure sources from this pathway are:
a) whole body external exposure to gamma radiation from the plume and from deposited material; and
b) inhalation exposure from the passing radioactive plume. The duration of the release leading to potential exposure could range from one half hour to days.
For the plume exposure pathway, shelter and/or evacuation would likely be the principal immediate protective actions to be recommended for the general public. When evacuation is chosen as the preferred protective measure, initial evacuation of a 360 area around the facility is desirable out to a distance of about 3 to 10 kilometres although initial efforts would, of course, be in the general downwind direction. The possible iodine prophylaxis, i.e., immediate administration of the thyroid blocking agent (usually potassium iodide), should also be considered. Therefore, one of the central issues in the emergency planning is to determine whether and at which projected thyroid radiation dose stable iodine should be given to the population (5).
In the process of establishing an international consensus on the values of the generic intervention levels (GILs) for urgent long-term protective measures, the International Atomic Energy Agency (IAEA) convened a number of technical meetings that resulted in preparation of Intervention Criteria in a Nuclear or Radiation Emergency (6). This safety guide represents the international consensus reached on principles for intervention on numerical values that subsequently became the basis of intervention guidance in the International Basic Safety Standards for Protection against Ionising Radiation and for the Safety of Radiation Sources (7) which have been issued jointly by the IAEA, Food and Agriculture Organization of the United Nations, International Labour Organization, Nuclear Energy Agency of the Organization for Economic Co-operation and Development, Pan American Health Organization and World Health Organization. The optimized generic intervention levels for urgent protective measures implemented in BSS are presented in Table 1.
Table 1. Recommended generic intervention levels for urgent protective measures
Protective action Generic intervention levels
(dose avertable by protective action)* Avertable dose periodSheltering 10 mSv 2 daysEvacuation 50 mSv** <1 weekIodine prophylaxis 100 mGy any
* Dose to be saved by protective action, that is the difference between the dose to be expected with the protective action and that to be expected without it.
** In some countries a value of 100 mSv of avertable dose is considered to be more realistic level for temporary evacuation. ICRP has recommended that evacuation would almost be justified for an avertable dose of 500 mSv (8, 9).
The values from the above table satisfy the following three basic principles:
1. The serious deterministic health effects of ionising radiation should be avoided.
2. The intervention should be justified in the sense that introduction of the protective measures should achieve more benefit than harm.
3. The levels at which the intervention is introduced and at which it is later withdrawn should be optimized, so that the protective measure will produce a maximum benefit.
The value for iodine prophylaxis was set to 100 mGy of avertable committed dose to a thyroid which was considered to be the optimal intervention level. The basis for setting the values for GILs is taking into account price and cost of equipment and human labour in implementation of particular protective action, costs of insurance and reinsurance and consequences of social disruptions caused either by implementation or non implementation of particular protective action. The prophylaxis is implemented by utilizing the pills of potassium iodide (KI), since a number of studies have unambiguously shown that radioiodine uptake by thyroid gland can be effectively blocked by administration of potassium iodine (10, 11, 12, 13). The KI pill works by saturating the thyroid with stable iodine. Potassium iodide is an oral antithyroid agent used as an adjunct to other antithyroid agents in the treatment of hyperthyroidism and thyrotoxicosis and preoperatively to induce thyroid involution. The drug has also demonstrated efficacy in treating cutaneous sporotrichosis. However, the administration of KI pills as a protectant of the thyroid gland from exposure to radioactive isotopes of iodine raises the questions of appropriate timing, as well as of possible side-effects (14, 15, 16, 17).
Potassium Iodide Contraindications
It should be noted that literature data on quantitative aspects of adverse reactions to potassium iodide have been rather scarce due to small size of the study groups, selection bias, limited follow-up etc. (14). Recently, however, a situation improved and some data are even available on-line (18). Potassium iodide was officially approved by the American Food and Drug Administration (FDA) in 1939 (16). The FDA has evaluated the medical and radiological risk of administering KI for thyroid blocking under nuclear emergency conditions, and has approved the over-the-counter sale of the drug for this purpose.
The Mechanism of Action: Potassium iodide exerts its action in the thyroid gland by inhibiting thyroid hormone synthesis and release. Consequently, thyroid gland vascularity is reduced, its tissue becomes firmer, thyroid cell size is reduced, follicular colloid reaccumulates, and bound iodine levels increase. As a protectant following radiation exposure, KI blocks the uptake of radioactive iodine isotopes by the thyroid gland, thereby minimizing the risk of radiation induced thyroid neoplasms. In treating sporotrichosis, the KI may work by enhancing the tissue response to infection.
Pharmacokinetics: Potassium iodide is administered orally and is absorbed from the gastro intestinal tract as iodinated amino acids. It demonstrates significant extracellular distribution, with most of the drug accumulating in the thyroid gland. Potassium iodide distributes into breast milk and crosses the placenta in amounts sufficient enough to cause fetal harm. Therapeutic effects from KI usually are observed within 24 hours after administration, with maximum effectiveness occurring after 1015 days of therapy. Potassium iodide is excreted renally.
Pregnancy: Potassium iodide crosses the placenta in amounts sufficient enough to cause fetal goiter and/or hypothyroidism. Prolonged use during pregnancy is not advised, however, potassium iodide has been used short term (e.g., 10 days) to manage labor induced thyrotoxic crisis and as treatment prior to thyroidectomy in pregnant women. Potassium iodide is excreted into breast milk. Rash or thyroid suppression can occur in the nursing infant, however, the American Academy of Pediatrics does not consider breast feeding a contraindication.
Potassium iodide should be used with caution in patients with sulfite hypersensitivity and/or asthma because some formulations of this drug contain sodium bisulfite. A higher frequency of sensitivity reactions occur in asthmatic patients compared to nonasthmatic patients. Potassium iodide is contraindicated in patients with acute bronchitis.
Potassium iodide should be used cautiously in patients with a renal dysfunction. Due to impaired renal filtering of electrolytes, an increase in serum potassium can occur in patients with renal impairment. Potassium iodide can also exacerbate hyperkalemia or myotonia congenita (Thomsen's disease). Serum potassium, in addition to potential signs and symptoms of potassium toxicity, should be monitored in these patients. Potassium iodide should also be used with extreme caution in the following circumstances: acute dehydration, heat cramps, adrenal insufficiency, and cardiac disease. Also, potassium iodide should be used with caution in patients with acne vulgaris as halogens in general can produce an acneiform rash or aggravate existing acne.
Potassium iodide should be used with extreme caution in patients with tuberculosis because pulmonary irritation and increased secretions may ensue. If possible, potassium iodide should be avoided in this patient population.
It is well known that chronic ingestion of iodine or iodine-generating compounds in amounts of ten or more times the daily requirements for a hormone biosynthesis in certain subjects leads to iodide goiter (11). Therefore, potassium iodide should be used with extreme caution in patients with iodine hypersensitivity. Patients at an increased risk of developing adverse effects caused by iodine include those with hypocomplementemic vasculitis, goiter, or autoimmune thyroid disease.
There have been reports that the administration of stable iodine for the prophylaxis of endemic goiter is associated with an increased incidence of a papillary carcinoma (19), although it is was not possible to quantitatively evaluate any stable iodine carcinogenic potential, especially after some radiation exposure has also occurred (6). Nevertheless, this potential militates against selecting intervention levels of only few mGy. Therefore, recommended generic intervention level for iodine prophylaxis in BSS has been established at 100 mGy (Table 1).
Intrathyroidal and extrathyroidal side effects that occurred after administering a single dose of KI were in details discussed by Nauman and Wolf (14) in a study on effects of iodide prophylaxis in Poland after the Chernobyl accident. There were no serious adverse reactions among the population of approximately 18 million people that were given KI, except for the two adults with known iodide sensitivity. As those two individuals had severe reactions following KI intake, this serves as a warning that such patients must be identified and educated about their sensitivity and excluded from the emergency preparedness prophylactic programmes.
KI effectiveness and dosage
The effectiveness of KI in protecting the thyroid gland, i.e. in blocking the uptake of radioiodine, depends strongly upon the time of intake relative to the start of exposure to radioactive iodine. Based upon the study performed by Ilin et.al. (10), which is also adopted by United States Nuclear Regulatory Commission (NRC) (20) the best results are obtained if KI is taken 1-2 hours before or immediately after the start of exposure. Taking the recommended dosages of KI just before or at the time of exposure can provide more than 90% blocking of radioactive iodine uptake by the thyroid (Figure 1). If KI is taken approximately 3-4 hours after the acute exposure, about 50% blocking could still occur. Once radioactive iodine has concentrated in the thyroid, KI is blocking its excretion. The KI dosage recommended by FDA is 130 mg/day (which contains 100 mg of stable iodine) for adults and children above 1 year and 65 mg/day for children below 1 year of age (20). The duration of protection is, like the extent of protection, also dose-related. That is, even a large single dose will not protect for much longer than approximately 36 hours (14). Therefore, KI should be administered for at least three days after the acute exposure to radioiodine, to prevent accumulation in a thyroid gland of radioiodine excreted from the other compartments of the body.
Iodide prophylaxis in Poland after the Chernobyl accident
The largest epidemiological study on the effects of KI prophylaxis ever performed was the one in Poland after the Chernobyl accident. The accident at Chernobyl nuclear power plant in Ukraine took place on April 26, 1986. Two explosions that occurred, the steam explosion followed by the explosion of hydrogen, expelled fission products as well as some material from fuel elements to the exterior. Because the graphite moderator ignited, the release acted as a prolonged elevated release. Consequently, volatile radioactive material accumulated in a cloud, reaching the height up to 7 km. It was estimated that 1.31018 Bq of 131I (i.e., 20% of the 131I core inventory) has been released (21). Increased air radioactivity was in Poland first detected on April 27, spectra showing that 80% of radioactivity were iodine isotopes (14). At noon on April 29, Minister of Health gave orders to prepare KI solutions in the centralized pharmacy for distribution in 11 most affected provinces. The following protocol for preparing KI doses was used:
a) 15 mg for newborns,
b) 50 mg for children 5 years or under,
c) 70 mg for all others
d) Because the cancer risk for adults was believed to be low, and some side-effects might be anticipated, iodide prophylaxis was not recommended to adults.
e) Iodide prophylaxis was recommended to lactating women, but was not mandatory.
Stable iodine was given as single dose of KI solution to 10.5 million of children and 7 millions of adults. Among children no serious side effects were seen while only two adults (with previously recorded iodine sensitivity) had severe respiratory distresses. However, non-thyroidal side effects of KI that occurred were more frequent than expected, vomiting being the most common. In addition, few cases of diarrhea and gastric complaints were noted, in both, children and adults, but it remained unclear to what extent this can be related to the administered iodide. The control values for side-effects in a population not-receiving KI are not available. Therefore, the relation of some of these complications to iodide rather than to panic conditions remains uncertain. Polish experiences showed that rapid response to such widespread nuclear accidents is as much a social problem as well as a medical or scientific one, requiring rapid organization of large number of people and facilities.
Iodide prophylaxis practice in the USA
In the USA, which is the country with largest number of operating nuclear power plants, the issue of stockpiling KI pills for prophylaxis of general public in the event of a nuclear reactor accident is still open, although it is generally accepted that KI is an effective thyroid blocking agent. The cost of KI is not prohibitive since a 130 mg tablet costs $.07. Therefore, supplying all residents within 8 km (i.e., within the emergency planning zone) of one of the United States' 107 operating nuclear reactors would cost on average $200,000 (although distributing and disposing of the supply would add costs). Also, the safety of the drug is not disputed. However, there is major disagreement whether having KI on hand would make some residents trust their fate to a pill rather than to evacuation. Namely, many federal states, as well as the nuclear industry, believe evacuation should be the first line of protective action in a nuclear emergency. KI can therefore create a false sense of security as well as ambiguity through choice (22). Nevertheless, the protective action to provide the public with a stable iodine remains at the option of state, and in some cases, local governments (23).
The high incidence of thyroid cancer in Belarus and Ukraine among children exposed to radiation following the Chernobyl nuclear plant explosion in 1986 (24) has caused many physicians and public health officials in the USA and other countries to reconsider the urgency of making KI readily available to the public. Consequently, supporters of stockpiling, contend that it would be negligent of the nuclear industry and of state and federal governments not to endorse what they call a simple and cheap insurance policy. For example, The American Thyroid Association through its Public Health Committee has strongly recommended the stockpiling of KI for prophylaxis in the event of a nuclear reactor accident (25).
Nuclear Regulatory Commission recently (summer 1998) decided that it would financially support the stockpiling of the KI pills, if federal states decide to stockpile them. Previously, NRC recommended that potassium iodine be available mainly for emergency workers, but not stored for general public. The U. S. Department of Health and Human Services is currently preparing guidance on the potassium iodide issue, which will be considered by NRC and Federal Emergency Management Agency (26).
KI and emergency response workers
In the acute phase of nuclear accident information provided by emergency response mobile units are essential for dose estimates needed for application of protective measures for general public (27, 28). Even in the countries that are excellently covered with fixed telemetric monitoring stations, mobile units capable of transferring in real time external dose-rate data together with corresponding locality data are useful for mapping radiation levels in locations not covered by fixed monitoring network (29). A primary function of mobile unit team monitoring is to locate the plume and assess its magnitude (usually with some form of the open-window vs. closed window surveys with the dose-rate meters). Therefore, in order to protect from radiation exposure the personnel involved, as well as to cover maximal number of locations in a given time, it is required that field measurements performed by the mobile units should consume as little time as possible. To provide the maximal protection for team personnel, respirators should be readily available, as well as KI pills. While for the use of respirators in several USA plants is established the action level of approximately 37 Bqm-3, criteria for administering KI pills vary between 0.1 and 0.25 (30). Generally, the principles for protection of workers of different categories that might be exposed to radiation in a nuclear emergency are in full details discussed in references (6, 7).
Concluding remarks
A number of studies have shown that radioiodine uptake by thyroid gland can be effectively blocked by administration of potassium iodine, provided that it occurs before or within few hours of exposure to iodine radioisotopes. Therefore, KI prophylactic programmes are important part of nuclear emergency preparedness. It is especially true for the highly populated areas that cannot be, for a number of reasons, effectively evacuated in short time. It should be noted that in 1989 the World Health Organization recommended preventive distribution of KI, and, to date, France and Switzerland have distributed it widely.
However, all individuals with iodide sensitivity have to be identified in order to prevent serious iodine-related side effects. That can be achieved through a public health care system.
In some countries it is recommended to stockpile KI in individual households. However, prior to that general public has to be well educated and informed about emergency preparedness principles. Like in many other countries in the Republic of Croatia this can be accomplished through national TV and radio network, teletext pages etc. Also, it would be useful to establish an emergency preparedness information server on Internet. This can be combined with the real-time information about background radiation on several locations in Croatia that is already available (31). If Croatia adopts the KI prophylactic programmes, the important question that remains to be solved by the competent authorities is to develop the most effective way of KI stockpiling and distribution or predistribution. Subsequently, the detailed stockpiling and predistribution distribution procedures should be implemented in emergency plans.
References
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30. Widner TE. Power Reactor Emergency Response Field Monitoring Practices in the United States. Health Phys, 1990:58;735-8.
31. Dr ~a v n i h i d r o m e t e o r o l o ak i z a v o d H r v a t s k e . P r i r o d n a d o z a z r a
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